Koru Medical Systems (Nasdaq:KRMD) announced today that it appointed Brent Rutland as its new VP of medical affairs. Rutland joins the Mahwah, New Jersey-based drug delivery technology developer with 27 years of experience in the space. Most recently, he served as a senior director for health outcomes at La Jolla Pharmaceutical Company. Among his previous […]
Iradimed withdraws 510(k) application for MR-compatible IV pump
Iradimed (Nasadq:IRMD) announced that it voluntarily withdrew an FDA 510(k) application for its new model MR IV pump. Winter Springs, Florida-based Iradimed said it learned that the FDA likely wouldn’t have time to finish clearance activities for the pending submission. Upon learning this, the company decided to voluntarily withdraw its application on Oct. 5. The […]
GlucoTrack to begin R&D for new long-term CGM
GlucoTrack (Nasdaq:GCTK) announced that it plans to expand its product pipeline with a R&D program for a long-term continuous glucose monitor (CGM). Rutherford, New Jersey-based GlucoTrack said it recently required related IP. It now intends to develop a long-term, implantable glucose management platform for the type 1 diabetes market. Initial data gives the company confidence […]
Ascensia completes Senseonics Eversense E3 European launch
Ascensia Diabetes Care announced that it successfully completed its initial European launch for the Senseonics (NYSE:SENS) Eversense E3. Eversense E3 represents Senseonics’ next-generation continuous glucose monitor (CGM) system. Eversense E3 can be used for up to six months (180 days). This doubles the wear time of its previous-generation CGM. Ascensia said in a news release […]
Analysts: Abbott, Dexcom to benefit from proposed CMS decision on CGMs
Analysts see a new proposed local coverage determination (LCD) from CMS as a potential boost for Dexcom (Nasdaq:DXCM) and Abbott (NYSE:ABT). The Centers for Medicare and Medicaid Services (CMS) yesterday published the LCD modifying coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history […]
How Qnovia aims to use inhaled therapeutics for smoking cessation
Led by a former tobacco company executive, Qnovia looks to offer nicotine replacement therapy through inhaled drug delivery. Brian Quigley spent just over 16 years at tobacco giant Altria. During his time there, he ran two U.S. business units, including the smokeless tobacco business. In July 2020, he joined founder and then-CEO at Qnovia (then […]
Rescue Biomedical wins $2.8M grant for nalaxone-releasing implant for opioid overdoses
Rescue Biomedical announced today that it received a $2.8 million grant from the National Institutes of Health for its opioid overdose treatment. West Lafayette, Indiana received a Fast-Track Small Business Innovation Research, or SBIR, grant from the NIH. The company develops technology that detects when a person is overdosing on an opioid and delivers naloxone […]
Senseonics offers equity grants under inducement plan
Senseonics (NYSE:SENS) announced today that it granted six new non-executive employees stock options under an inducement plan. Germantown, Maryland-based Senseonics granted the employees non-qualified stock options. The options allow them to purchase an aggregate of 78,000 shares of the company’s common stock. It represents an inducement for such employees to join the company, according to a […]
Study shows reduced HbA1c with Abbott FreeStyle Libre 2 CGM
Abbott (NYSE:ABT) announced today that a new study supports the use of its FreeStyle Libre 2 continuous glucose monitor (CGM). The study, published in The New England Journal of Medicine, evaluated adults with type 1 diabetes and suboptimal glycemic control. It demonstrated significant reductions in glycated hemoglobin (HbA1c) compared to self-monitoring of blood glucose. Subjects […]
Published data backs digital therapeutic for diabetes from Better Therapeutics
Better Therapeutics (Nasdaq:BTTX) announced today that newly published data supports its digital therapeutic for type 2 diabetes. San Francisco-based Better Therapeutics develops the BT-001 prescription digital therapeutic (PDT). It potentially represents the first-in-class PDT using cognitive behavioral therapy (CBT) to treat type 2 diabetes. In July, the company completed the pivotal trial for its BT-001 digital therapeutic […]